There are about 11304 clinical studies being (or have been) conducted in Denmark. The country of the clinical trial is determined by the location of where the clinical research is being studied. Most studies are often held in multiple locations & countries.
Previous research has shown the efficacy of (combinations of) individual components of cognitive behavioral therapy for insomnia (CBT-I), namely sleep hygiene education, sleep restriction, stimulus control therapy, deactivation/relaxation training, and cognitive therapy. However, their relative effects, i.e., their effects in direct comparison with each other, are yet to be assessed. By means of the Multiphase Optimization Strategy (MOST), this study aims to investigate the components' relative efficacy in order to identify the most effective component or combination of components for digitized treatment of chronic insomnia. A future study will verify this intervention's effect in a randomized controlled trial (RCT).
Design and methods 12 athletes with T1D and 12 healthy athletes are included in a prospective experimental randomized, cross-over study. Athletes are provided with a Dexcom G6 CGM to measure glucose excursions before, during and after exercise and a Holter ECG-E-patch to measure HRV. Psychological stress levels are assessed from Competitive State Anxiety Inventory-2. The athletes are studied on two occasions: Day 1: 5K running competition and Day 2: 5K high intensity training session (running) in the athletes' regular training environment. Endpoints Primary endpoints: Change in plasma glucose from start of exercise to end of exercise during competition compared to training. Secondary endpoints: Hormonal response (cortisol, adrenalin, noradrenaline). Changes in heart rate and HRV before, during and after exercise. CGM-glucose and plasma glucose discrepancies.
Spinal cord injury (SCI) is a devastating life event with long term consequences both physically and mentally. SCI is defined as either complete or incomplete according to the International Standards of the Neurological Classification of SCI. The primary consequence of a SCI is paralysis/partial paralysis affecting the person's ability to independently functioning in everyday life e.g. in and out of bed, sit to stand and walking. To regain the ability to transfer and walk the most important prerequisite is to rebuild as much strength as possible in the lower extremities. The optimal training paradigm to increase strength in partial paralysed muscles is unclear. Rehabilitation robots are upcoming methods to treat sensorimotor deficits after SCI. The rehabilitation robot ROBERT might contribute to enhance muscle strength for people with very weak strength following an incomplete SCI. The overall objective of this Ph.D project is to investigate the feasibility and effect size of a muscle strength training intervention assisted by ROBERT® for patients with SCI and severe paresis (muscle strength 1-3 in hip flexion).
There is a strong case for treating diseases of both the upper and lower airways (global airways) simultaneously because they share the same inflammatory mechanisms. About 9% have chronic sinusitis (CRS) and 4% of the Danish population are diagnosed with CRS with nasal polyps (CRSwNP)) and 7-10% have asthma. CRS has a multifactorial background, with CRSwNP characterized by Type 2 inflammation, and approximately 50% with Type 2 CRSwNP also have co-morbid asthma. Well-treated CRS has an impact on asthma control, and well-treated asthma has an impact on CRS. Several studies show that patients with asthma have low adherence, but only a few if any of studies are available on adherence in CRS. Aim: To investigate the effect of systematic and structured nursing supervision in patients with CRSwNP and asthma primarily on adherence. Hypothesis and research questions: Patients with respiratory diseases can improve their adherence to their non-medical and medical treatment for CRSwNP/CRS and asthma by systematic and structured nursing supervision compared to patients who receive usual care. In a randomized clinical trial, we will investigate whether the level of adherence measured by the questionnaire MARS-5-N and MARS-5- L in patients with CRSwNP and asthma can be improved by 7 points after systematic and structured nursing guidance at baseline visit and controlled after four months - compared with those patients who have not received the above guidance. Primary outcome: is change in adherence rate measured by the MARS-5-N/L questionnaire in patients with CRSwNP and asthma can be improved by 4 points after systematic and structured nursing guidance at the initial visit and controlled after four months - compared with patients who have not received the above guidance. Inclusion Criteria: Adherence to MARS- 5 L/N ≤35 at first visit, diagnosed with asthma (with/without allergic rhinitis) at initial visit, diagnosed with CRSwNP, able to use smartphone, ACQ ≥1.2 or ACT≤15 (partially uncontrolled asthma), >18 years of age, SNOT-22 score ≥35 Exclusion Criteria: - Adherence to MARS-5- L/N >35 points at first visit,do not have smartphone, does not read/speak English, other illness requiring regular medication, pregnancy/pregnancy that started during the study, server psychological comorbidities Questionnaires: Patients must answer the following questionnaires at baseline and at 4 months follow up ESS, SNOT-22, ACQ-7, ACT, MiniAqLq, HADS, STARR-15
The purpose of this study is to evaluate the pharmacodynamics, safety, tolerability, pharmacokinetics, and efficacy of RO7204239, a humanized monoclonal antibody that binds to human latent myostatin, in ambulant adult participants with facioscapulohumeral muscular dystrophy (FSHD).
Phase 2 study to evaluate the efficacy, safety and tolerability of SLN360 administered subcutaneously (SC) compared with placebo in adult participants with elevated lipoprotein(a) at high risk of atherosclerotic cardiovascular disease events
This is an observational study in which data from people with chronic kidney disease (CKD) and type 2 diabetes (T2D) who have already started or will start CKD or T2D treatment are collected and studied. In observational studies, only observations are made without specified advice or interventions. People receiving the following CKD or T2D treatments as recommended by their doctors will be included: - Sodium-glucose cotransporter 2 inhibitors (SGLT2i), - Glucagon-like peptide-1 receptor agonists (GLP-1 RA), - Steroidal mineralocorticoid receptor antagonists (sMRA), - Finerenone, a non-steroidal mineralocorticoid receptor antagonist (nsMRA) - Other nsMRA (only in Japan) Kidneys filter extra water and waste from the blood and make urine. CKD is a long-term, progressive decrease in the kidneys' ability to properly filter blood. In people with T2D, the body does not make enough of a hormone called insulin or does not use insulin well enough, resulting in high blood sugar levels that can cause damage to the kidneys. As a result, CKD can occur as a complication of T2D. The new drug, finerenone, works by blocking certain proteins, called mineralocorticoid receptors. An increased stimulation of these proteins is thought to damage the kidneys. By lowering their stimulation, finerenone reduces the risk of progressive worsening of the kidney disease. Finerenone is available and approved in several countries for doctors to prescribe to people with CKD and T2D. The main purpose of the study is to collect and describe characteristics of participants in each treatment group who have started or will start treatment before and after finerenone became available. To do this, the researchers will collect data on: - Patient characteristics (e.g., age sex) of the participants - Clinical characteristics (e.g., history of CKD and T2D, heart and liver health, other health problems) of the participants - Treatments for T2D and CKD - Other medications used Data will be grouped by type of treatment that is initiated (e.g., SGLT2i, a GLP-1 RA, a sMRA, finerenone, or other nsMRA). Two time periods will be compared. Study period I is the time until finerenone became available in the respective country, starting from 2012 (2014 for Japan). Study period II will begin when finerenone becomes available in the respective country and will end at the end of the study (planned in September 2024). Researchers will also collect data on treatment patterns and changes for each type of treatment in both time periods. Health care data will be collected from various sources in five countries (e.g., Denmark, the Netherlands, Spain, Japan, and the US). The patients will receive their treatment as prescribed by their doctors during routine practice according to the approved product information. Each patient will be in the study from first use (in Study period I and II) of one of the listed drug classes until: - End of study - The data are somehow no longer available - The patient leaves or has to leave the study
In brief the study aims to investigate how nursing home residents receiving dog visits respond to contact with the dog, by comparing visits with and without a dog present. The investigators will measure the response with non-invasive measures of the immediate physiological response, and objective behavioural measurements to quantity the activity and the actual amount and intensity of contact to the dog.
1. Abstract Introduction Coronary artery calcification (CAC) and especially progression in CAC is a strong predictor of acute myocardial infarction and cardiovascular mortality. A substudy in the recent Danish study, AVADEC, suggested a protective role of supplementation with vitamin K2 and D in the development of CAC. This finding should be interpreted with caution, but the perspective is very interesting. In this study, we will examine the effect of the supplementation on progression of CAC in men and women with severe CAC. We hypothesize that the supplementation will slow down the calcification process. Method and analysis In this multicenter and double-blinded placebo-controlled study, 400 men and women with CAC score ≥ 400 are randomized (1:1) to treatment with vitamin K2 (720 µg/day) and vitamin D (25 µg/day) or placebo treatment (no active treatment) for two years. Exclusion criteria are treatment with vitamin K antagonist or coagulation disorders. To evaluate CAC score, a non-contrast CT-scan is performed at baseline and repeated after 12 and 24 months of follow-up. Primary outcome is difference in CAC score from baseline to follow-up at two years. Intention-to-treat principle is used for all analyses. Ethics and dissemination There are no reported adverse effects associated with the use of vitamin K2. Prior to inclusion, the protocol will be approved by the Regional Scientific Ethical Committee for Southern Denmark and the Data Protection Agency. It will be conducted in accordance with the Declaration of Helsinki. Positive as well as negative findings will be reported.
Patients with diabetes have an increased risk of sudden cardiac death compared to the general population. Severe hypoglycemia is associated with an increased risk of cardiovascular (CV) disease (CVD) and events, including cardiac arrhythmias and sudden cardiac death; likewise, increased glycemic variability is associated with macrovascular complications and increased mortality. The physiological mechanisms linking hypoglycemia and glycemic variability to CVD and CV events remain unclear. Myocardial work and mechanical dyssynchrony will be measured by speckle tracking echocardiography during euglycemia, hypoglycemia and hyperglycemia in individuals with type 1 diabetes, type 2 diabetes, and without diabetes. Echocardiographic images from three experimental clamp studies - Hypo-Heart 1 (sub-study 1), Hypo-Heart 2 (sub-study 2) and Rapid-Heart - will be included in this study.